Introducer with hemostasis mechanism
An introducer sheath includes an elongate shaft having a proximal end, a distal end and a lumen extending therebetween. An actuatable hemostasis valve in a hub is adjacent the proximal end of the elongate shaft and may be used to prevent blood from escaping from the elongate shaft. The introducer sheath may also have a a self-expanding funnel adjacent the distal end of the elongate shaft.
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The present application is a non-provisional of, and claims the benefit of U.S. Provisional Patent Application No. 62/850,179 filed on May 20, 2019; the entire contents of which are incorporated herein by reference.
CROSS-REFERENCE TO RELATED PATENT DOCUMENTSThe present application is related to U.S. patent application Ser. No. 16/812,865 filed Mar. 9, 2020; the entire contents of which are incorporated herein by reference.
BACKGROUNDLess invasive vascular procedures typically involve the use of an introducer sheath which provides access to a vessel such as a vein or artery so that a catheter or other instrument may be easily inserted into the vessel and advanced to a target treatment location.
In the drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views. Like numerals having different letter suffixes may represent different instances of similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various examples discussed in the present document.
Less invasive vascular procedures typically involve the use of an introducer sheath which provides access to a vessel such as a vein or artery so that a catheter or other instrument may be easily inserted into the vessel and advanced to a target treatment location. While many commercially available introducer sheaths perform well, in some circumstances the introducer sheaths may leak blood, may be complex to operate, or may have a profile (e.g. diameter) that is larger than desired. It would therefore be desirable to provide improved introducer sheaths that overcome at least some of these challenges.
Specific examples of the disclosed device, delivery system, and method will now be described with reference to the drawings. Nothing in this detailed description is intended to imply that any particular component, feature, or step is essential to the invention.
Delivery SystemReferring initially to
Further details of a transcatheter mitral valve or any prosthesis that may be used with any of the delivery devices described herein, along with other related delivery catheters are described in U.S. Pat. No. 8,579,964 to Lane et. al., the entire contents of which are incorporated by reference herein.
Generally, delivery handle assembly 4 includes a distal actuator such as a thumbwheel 11 and a proximal actuator such as a thumbwheel 12, both of which are integrally associated with the delivery handle assembly 4, which is comprised of an A-side delivery handle housing 22, and a B-side delivery handle housing 23. Distal thumbwheel 11 and proximal thumbwheel 12 are also rotatably positionable with respect to the delivery handle assembly 4, serving as actuators by way of internal threads (not shown) and enabling translational control of various catheters within the delivery catheter assembly 7, further evidence of which will be detailed in a later section. The delivery handle assembly 4 is operatively coupled to the valve capsule assembly 8 via the delivery catheter assembly 7, which functions in one aspect as a motion translation agent. In some examples, the delivery handle assembly 4, delivery catheter assembly 7 and valve capsule assembly 8 can form a delivery system 26. In some examples, the steering handle 5 and steerable catheter assembly 7 can form a steering guide 10, which provides a path through which the delivery system 26 can translate and rotate, and from which it may take its shape in order to traverse tortuous vasculature during implantation. Taken altogether, the delivery system 26 and steering guide 10 can form the transseptal delivery system 1.
Valve capsule assembly 8 may exhibit various constructions. For example, the distal capsule 14 and proximal capsule 13 may be formed from substantially rigid, stainless steel, polymer, metal or otherwise rigid tubing, from collapsible, flexible tubing, or from shape-settable exotic metal alloys which exhibit shape memory characteristics and are actuated by temperature gradients inherent to the human physiology, such as nitinol. Presently, portions of the valve capsule assembly 8 can be translatably controlled by the turning of either the distal thumbwheel 11, or the proximal thumbwheel 12, located in the delivery handle assembly 4. By rotating the distal thumbwheel 11, the proximal capsule 14 can be translatably positioned along the axis of the capsule assembly 8 in order to reveal certain portions of the prosthesis such as a prosthetic mitral valve for example, as shown in
With reference to
Generally, the steering guide 10 includes an interface section 9 that is comprised of an O-ring type interface of cylindrical shape similar to a gasket, which is embedded within A and B side steering handle housings 24 and 25 respectively, the A-side steering handle housing 24, the B-side steering handle housing 25, an actuator such as a steering thumbwheel 16, wherein the steering thumbwheel can have a generally cylindrical shape, a catheter strain relief 27, and a steerable catheter assembly 6. The steering thumbwheel can additionally include one or more protrusions separated by one or more recesses or slots to provide a surface to facilitate grasping and turning the wheel. In some examples, the steering thumbwheel can have a textured surface with ribs to facilitate grasping and turning the wheel. The interface section 9 provides a dynamic seal between the steering handle 5 and the delivery catheter assembly 7 thus allowing for slidably sealed catheter translation thereby; the delivery catheter assembly thus may traverse therethrough and exit towards the distal end of the steering guide 10 at the terminal, articulated end 15 of the steerable catheter assembly 6. While the interface section 9 provides a dynamic seal, the delivery catheter assembly 7 may still translate and rotate within the steering guide 10, in order to define accurate positioning within a patient, at the target implant site. Detail regarding the implant procedure and target implant site will be discussed in a later section. In order to actuate the steerable portion of the steering catheter assembly 6, the steering thumbwheel 16 must be turned. When the steering thumbwheel 16 is turned, the articulated end 15 of the steerable catheter assembly 6 will bend in the same direction as the direction of thumbwheel turning. This motion translation is achieved through the use of internal pull wires 308, as depicted for example in
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Any example of a valve capsule assembly may be used in any delivery catheter as described herein. With particular reference to
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The atrial skirt portion 1716 forms a flanged region that helps to anchor the prosthetic valve to the atrium, above the mitral valve. The atrial skirt includes a plurality of triangular fingers which extend radially outward from the anchor to form the flange. The posterior 1704 portion of the atrial skirt 1716 is generally round or circular, while a portion of the anterior 1702 part of the atrial skirt 1716 is flat. Thus, the atrial skirt region may have a D-shaped cross-section. This allows the prosthetic valve to conform to the patient's cardiac anatomy without obstructing other portions of the heart, as will be discussed below. Each triangular finger is formed from a pair of interconnected struts. The triangular fingers of the atrial skirt generally are bent radially outward from the central axis of the prosthetic valve and lie in a plane that is transverse to the valve central axis. In some examples, the atrial skirt lies in a plane that is substantially perpendicular to the central axis of the valve. The anterior portion 1702 of the atrial skirt 1706 optionally includes an alignment element 1714 which may be one or more struts which extend vertically upward and substantially parallel to the prosthetic valve. The alignment element 1714 may include radiopaque markers (not illustrated) to facilitate visualization under fluoroscopy. The alignment element helps the physician to align the prosthetic valve with the native mitral valve anatomy, as will be discussed later.
Disposed under the atrial skirt region is the annular region 1720 which also has a collapsed configuration for delivery, and an expanded configuration for anchoring the prosthetic valve along the native valve annulus. The annular region is also comprised of a plurality of interconnected struts that form a series of cells, that may be closed. Suture holes 1721 in some of the struts allow tissue or other coverings (not illustrated) to be attached to the annular region. Covering all or a portion of the anchor with tissue or another covering helps seal the anchor against the heart valve and adjacent tissue, thereby ensuring that blood is funneled through the valve, and not around it. The annular region may be cylindrical, but in any example has a posterior portion 1704 which is circular, and an anterior portion 1702 which is flat, thereby forming a D-shaped cross-section. This D-shaped cross-section conforms better to the native mitral valve anatomy without obstructing blood flow in other areas of the heart.
The lower portion of the prosthetic valve includes the ventricular skirt region 1728. The ventricular skirt region also has a collapsed configuration for delivery, and an expanded configuration for anchoring. It is formed from a plurality of interconnected struts that form a series of cells, that may be closed, that can radially expand. The ventricular skirt in the expanded configuration anchors the prosthetic valve to the ventricle by expanding against the native mitral valve leaflets. Optional barbs 1723 in the ventricular skirt may be used to further help anchor the prosthetic valve into the ventricular tissue. Barbs may optionally also be included in the atrial skirt portion as well as the annular region of the anchor. Additionally, optional suture holes 1721 in the ventricular skirt may be used to help suture tissue or another material to the ventricular skirt region, similarly as discussed above. The anterior 1702 portion of the ventricular skirt may be flat, and the posterior 1704 portion of the ventricular skirt may be circular, similarly forming a D-shaped cross-section to anchor and conform to the native anatomy without obstructing other portions of the heart. Also, the lower portions of the ventricular skirt serve as deployment control regions since the lower portions can remain sheathed thereby constraining the ventricular skirt from radial expansion until after the optional ventricular trigonal tabs and posterior tab have expanded, as will be explained in greater detail below.
The ventricular skirt portion may optionally also include a pair of ventricular trigonal tabs 1724 on the anterior portion of the anchor (only 1 visible in this view) for helping to anchor the prosthetic valve as will be discussed in greater detail below. The ventricular skirt may also optionally include a posterior tab 1726 on a posterior portion 1704 of the ventricular skirt for anchoring the prosthetic valve to a posterior portion of the annulus. The trigonal tabs 1724 or the posterior tab 1726 are tabs that extend radially outward from the anchor, and they are inclined upward in the upstream direction.
The actual valve mechanism is formed from three commissures posts (also referred to as commissures) 1713 which extend radially inward toward the central axis of the anchor in a funnel or cone-like shape. The commissures 1713 are formed from a plurality of interconnected struts that create the triangular shaped commissures. The struts of the commissures may include one or more suture holes 1721 that allow tissue or a synthetic material to be attached to the commissures. In this exemplary example, the valve is a tricuspid valve, therefore it includes three commissures 1713. The tips of the commissures may include a commissure tab 1712 (also referred to as a tab) for engaging a delivery catheter. In this example, the tabs have enlarged head regions connected to a narrower neck, forming a mushroom-like shape. The commissures may be biased in any position, but may angle inward slightly toward the central axis of the prosthetic valve so that retrograde blood flow forces the commissures into apposition with one another to close the valve, and antegrade blood flow pushes the commissures radially outward, to fully open the valve.
An introducer sheath may be used to facilitate access to a vein or artery of the patient so that any of the delivery catheters or delivery systems disclosed herein may be introduced into the vein or artery and deliver any one of prostheses disclosed herein to a target treatment region in the patient. Not only does the introducer sheath facilitate vascular access but the introducer sheath also may have a hemostasis valve that prevents blood leakage due to backflow of blood from the pressurized vein or artery out of the proximal end of the sheath.
The hub 1904 has a lumen extending through the hub and that is fluidly coupled with the lumen in the elongate shaft. Therefore, fluid introduced from the proximal end of the hub may pass through the hub, through the lumen of the elongate shaft and exit the distal end of the elongate shaft. Thus, when the sheath is disposed in a vessel, blood will flow from the vessel out the hub and therefore the introducer sheath may include a hemostasis valve 1906 to control the backflow. The hemostasis valve is shown in the closed configuration in
The hemostasis valve 1906 is an actuatable hemostasis valve that an operator may control to open and close the hemostasis valve as desired. In the open position, the lumen in the hub is open and therefore fluid may be introduced into the introducer sheath and exit the distal end of the sheath, or fluid may be introduced into the sheath from the distal end of the sheath and exit at the proximal end of the hub. Additionally, delivery catheters, delivery systems, dilators, guidewires, or any other device may be inserted into or removed from the introducer sheath when the hemostasis valve is open. When the hemostasis valve is in the closed configuration, the hub lumen is closed and therefore fluid cannot pass past the hemostasis valve and exit out of the proximal end of the hub. Additionally, in any example, the hemostasis valve in the closed position may close tightly enough around a guidewire, delivery catheter, delivery system, dilator, or any other device disposed in the introducer sheath thereby preventing axial movement thereof relative to the introducer sheath.
Optional ports 1910, 1914 (also sometimes referred to as hemo-ports herein) may be coupled to the hub and both may be fluidly coupled with the hemostasis valve 1906. Ports 1910, 1914 may also optionally include a valve such as a one-way, two-way, or other multi-way stopcock 1912, 1916 to control flow in or out of the ports 1910, 1914. The stopcocks may have Luer connectors to facilitate releasable coupling with another medical device such as tubing, a syringe, or other item. A section of tubing may be used to fluidly couple the stopcocks with the hub and hemostasis valve. A pump may be used to actuate the hemostasis valve. Here, syringe 1920 acts as a manually controllable pump to introduce fluid into the hub and actuate the hemostasis valve. The syringe 1920 includes an outer syringe barrel 1924 that holds fluid 1928 such as saline or a gas like nitrogen. An operator may manually actuate syringe plunger 1922 to slidably move rubber seal 1926 through the syringe barrel as shown by arrow 1918 to push the fluid 1928 out of the syringe into the hub. The stopcock 1912 may be actuated into different positions in order to open or close various fluid pathways which is shown in the open position for fluid delivered by the syringe while a second port on the stopcock is shown in the closed position. As fluid is introduced from syringe 1920 through port 1910 into hub 1904, hemostasis valve 1906 will move into the closed position. The second port 1914 may be disposed in the open position to allow fluid from the hub to vent out into the surrounding environment. Once the hemostasis valve has been closed, both ports 1910, 1914 may be closed so that the hemostasis valve remains in the closed position.
The hub 2028 includes fasteners 2004 such as screws, a hub cap 2006, sealing elements 2008, 2010, 2026 such as O-rings, proximal and distal sealing elements 2014, support elements 2012, sealing bladder 2016, and hub body 2018.
The fasteners 2004 secure the hub cap 2006 to the proximal sealing element 2014. Sealing elements 2008, 2010 such as O-rings prevent fluid leakage therebetween. The proximal and distal sealing elements 2014 provide attachment locations for the sealing bladder 2016 where the proximal end of the sealing bladder is coupled to the distal end of the proximal sealing element, and the distal end of the sealing bladder is coupled to the proximal end of the distal sealing element. The sealing bladder may be a cylindrical tube with a single channel extending therethrough and formed form a resilient and flexible material than can expand and collapse. Support elements such as elongate rods 2012 are coupled to the proximal and distal sealing elements to provide a rigid structure so that the proximal and distal sealing elements do not move relative to one another. The assembly of the proximal and distal sealing elements, support elements and the sealing bladder form the actuatable hemostasis valve which can then be inserted into the hub body 2018 leaving an annular space therebetween which can be pressurized with fluid or depressurized. Pressurization of the annular space collapses the bladder closing the hemostasis valve, and depressurizing the annular space allows the bladder to expand thereby opening the hemostasis valve. Sealing element 2026 prevents fluid leakage between the distal sealing element and a distal portion of the hub body. Additional details on the elements of the hub and actuatable hemostasis valve are disclosed below.
Holes 2506 may be threaded to receive fasteners such as screws 2004 shown in
After a surgical cutdown or Seldinger procedure has been performed to introduce a guidewire into a vessel, a first dilator 2604 may be advanced over the guidewire 2602 through the skin and puncture site 2606 into the vessel 2608 as shown in
In
Any catheter, delivery system or other instrument such as any of the delivery catheters and delivery systems disclosed herein carrying any of the prostheses disclosed herein can then be loaded over the guidewire and advanced through the sheath into the vessel. The delivery catheter can then be advanced to a target treatment region where the prosthesis is then deployed. For example, a prosthetic mitral valve may be carried by a prosthesis delivery catheter and delivered to the native mitral valve where the prosthetic mitral valve is deployed to repair a diseased or damaged native mitral valve, using any of the previously described methods disclosed herein. The hemostasis valve may be actuated into an open or closed position by introducing fluid or removing fluid from the hub as previously described, and as needed. Once the procedure is complete, the guidewire and sheath may be removed from the patient.
Purging StrawAn optional purging straw may be used to help flush the prosthesis and capsule on the delivery catheter to remove air and wet the device before introduction into the patient's vascular system.
In
In the situation where the prosthesis does not deploy correctly, an optional funnel may be used to help capture and resheath the prosthesis. In
The actuatable hemostasis valve may be actuated between the open and closed positions as previously described to allow or prevent fluid flow through the introducer sheath as well as anchoring or allowing movement of the purging straw and/or delivery catheter through the introducer sheath.
The following, non-limiting examples, detail certain aspects of the present subject matter to solve the challenges and provide the benefits discussed herein, among others.
Example 1 is an introducer sheath that comprises an elongate shaft having a proximal end, a distal end, and a lumen extending therebetween; a hub coupled to the proximal end of the elongate shaft, the hub having a lumen extending therethrough, and the hub lumen fluidly coupled with the elongate shaft lumen; and an actuatable hemostasis valve disposed in the hub, the actuatable hemostasis valve actuatable between an open configuration and a closed configuration, wherein in the open configuration the actuatable hemostasis valve is disposed in an expanded configuration that allows fluid to flow past the actuatable hemostasis valve, and wherein in the closed configuration the actuatable sealing element is disposed in a collapsed configuration that seals the hub lumen and prevents fluid from flowing past the actuatable hemostasis valve.
Example 2 is the introducer of Example 1, further comprising a purging straw slidably disposed in the hub lumen, the purging straw comprising an elongate shaft with a proximal end, a distal end, and a lumen extending therebetween.
Example 3 is the introducer of any of Examples 1-2, wherein in the closed configuration the actuatable hemostasis valve is in the collapsed configuration and is configured to collapse against the purging straw and prevent axial movement of the purging straw relative to the hub.
Example 4 is the introducer of any of Examples 1-3, wherein in the closed configuration the actuatable hemostasis valve is in the collapsed configuration and is configured to collapse against a catheter disposed in the hub lumen and prevent axial movement of the catheter relative to the hub.
Example 5 is the introducer of any of Examples 1-4, wherein the purging straw comprises a stopping element coupled to the proximal end of the purging straw, the stopping element configured to limit advancement of the purging straw into the hub lumen.
Example 6 is the introducer of any of Examples 1-5, wherein the purging straw comprises a flared funnel coupled to a distal end of the purging straw.
Example 7 is the introducer of any of Examples 1-6, wherein the flared funnel is self-expanding.
Example 8 is the introducer of any of Examples 1-7, wherein the flared funnel comprises a coating or cover coupled thereto.
Example 9 is the introducer of any of Examples 1-8, wherein the hub comprises one or more ports fluidly coupled therewith, the one or more ports configured to allow fluid to enter or exit the hub.
Example 10, is the introducer of any of Examples 1-9, wherein the one or more ports comprise three ports, the first port fluidly coupled with the actuatable hemostasis valve and configured to allow introduction of a fluid into the actuatable hemostasis valve, the second port fluidly coupled with the actuatable hemostasis valve and configured to allow fluid to vent out of the actuatable hemostasis valve, and the third port fluidly coupled with the hub lumen and configured to introduce fluid into the hub lumen or to allow fluid to be removed from the hub lumen.
Example 11 is the introducer of any of Examples 1-10, further comprising a dilator with a tapered distal tip, the dilator slidably disposed through the elongate shaft lumen.
Example 12 is the introducer of any of Examples 1-11, wherein the actuatable hemostasis valve comprises a sealing bladder having an expanded configuration and a collapsed configuration, wherein in the expanded configuration the elongate shaft lumen is patent, and wherein in the collapsed configuration the elongate shaft lumen is obstructed.
Example 13 is the introducer of any of Examples 1-12, wherein the actuatable hemostasis valve comprises a plurality of support elements, a proximal sealing element, a distal sealing element and a sealing bladder, and wherein the hub comprises a hub body and a hub cap, wherein opposite ends of the sealing bladder are coupled to the upper and lower sealing elements, wherein the plurality of support elements are disposed between the upper and lower sealing elements, wherein the actuatable hemostasis valve is disposed in the hub body, and wherein the hub cap is coupled to a proximal end of the hub body.
Example 14 is a system for introducing a medical device into a patient, said system comprising: an introducer sheath comprising an elongate shaft, a hub coupled to a proximal end of the elongate shaft, and an actuatable hemostasis valve disposed in the hub, the actuatable hemostasis valve actuatable between an open configuration and closed configuration, wherein in the open configuration fluid is configured to flow past the actuatable hemostasis valve, and wherein in the closed configuration the fluid is prevented from flowing past the actuatable hemostasis valve.
Example 15 is the system of Example 14, further comprising a purging straw slidably disposed in the introducer sheath, wherein the purging straw comprises an elongate shaft with a lumen extending therethrough.
Example 16 is the system of any of Examples 14-15, wherein the actuatable hemostasis valve in the closed configuration engages the purging straw and prevents axial movement of the purging straw relative to the intruder sheath.
Example 17 is the system of any of Examples 14-16, further comprising a dilator with a tapered distal tip slidably disposed in the introducer sheath.
Example 18 is the system of any of Examples 14-17, further comprising a delivery catheter slidably disposed in the introducer sheath.
Example 19 is the system of any of Examples 14-18, wherein the delivery catheter comprises a delivery catheter carrying a prosthetic cardiac valve.
Example 20 is the system of any of Examples 14-19, wherein the purging straw comprises a stopping element coupled to a proximal end of the purging straw, the stopping element configured to limit advancement of the purging straw into the introducer sheath.
Example 21 is the system of any of Examples 14-20, wherein the purging straw comprises a flared funnel coupled to a distal end of the purging straw.
Example 22 is the system of any of Examples 14-21, wherein the flared funnel is self-expanding.
Example 23 is the system of any of Examples 14-22, wherein the flared funnel comprises a coating or cover coupled thereto.
Example 24 is the system of any of Examples 14-23, wherein the hub comprises one or more ports fluidly coupled therewith, the one or more ports configured to allow fluid to enter or exit the hub.
Example 25 is the system of any of Examples 14-24, wherein the one or more ports comprise three ports, the first port fluidly coupled with the actuatable hemostasis valve and configured to allow introduction of a fluid into the actuatable hemostasis valve, the second port fluidly coupled with the actuatable hemostasis valve and configured to allow fluid to vent out of the actuatable hemostasis valve, and the third port fluidly coupled with the hub and configured to introduce fluid into the hub or to allow fluid to be removed from the hub.
Example 26 is the system of any of Examples 14-25, wherein the actuatable hemostasis valve comprises a sealing bladder having an expanded configuration and a collapsed configuration, wherein in the expanded configuration fluid is configured to flow past the actuatable hemostasis valve, and wherein in the collapsed configuration fluid is obstructed from flowing past the actuatable hemostasis valve.
Example 27 is a method of introducing a medical device into a patient, said method comprising: inserting an introducer sheath into a blood vessel; slidably disposing an elongate shaft into the introducer sheath; advancing the medical device through the introducer sheath to a target treatment area; actuating an actuatable hemostasis valve in the introducer sheath to collapse against the elongate shaft thereby preventing fluid from flowing past the actuatable hemostasis valve; performing a treatment on the patient at the target treatment area with the medical device; actuating the actuatable hemostasis valve in the introducer sheath to expand away from the elongate shaft thereby allowing fluid to flow past the actuatable hemostasis valve; and removing the elongate shaft from the introducer sheath.
Example 28 is the method of Example 27, wherein the actuatable hemostasis valve comprises a sealing bladder and wherein actuating the actuatable hemostasis valve to collapse against the elongate shaft comprises collapsing the sealing bladder around the elongate shaft thereby constraining axial movement of the elongate shaft relative to the introducer sheath.
Example 29 is the method of any of Examples 27-28, wherein the actuatable hemostasis valve comprises a sealing bladder and wherein actuating the actuatable hemostasis valve to expand away from the elongate shaft comprises expanding the sealing bladder away from the elongate shaft thereby allowing axial movement of the elongate shaft relative to the introducer sheath.
Example 30 is the method of any of Examples 27-29, wherein the elongate shaft comprises a purging straw, the method further comprising filling the purging straw with a liquid and purging a gas out of the purging straw.
Example 31 is the method of any of Examples 27-30, wherein slidably disposing the elongate shaft comprises advancing the purging straw until a stopping element on a proximal end of the purging straw abuts a proximal portion of the introducer sheath.
Example 32 is the method of any of Examples 27-31, further comprising radially expanding a flared funnel on a distal end of the purging straw to facilitate recapture of the medical device.
Example 33 is the method of any of Examples 27-32, wherein the introducer sheath comprises a hub coupled to a proximal end of the introducer sheath, and wherein the actuatable hemostasis valve comprises a sealing bladder in the hub, and wherein actuating the actuatable hemostasis valve to collapse against the elongate shaft comprises introducing a fluid into the hub to collapse the sealing bladder.
Example 34 is the method of any of Examples 27-33, wherein actuating the actuatable hemostasis valve to collapse against the elongate shaft further comprises venting a fluid out of the hub.
Example 35 is the method of any of Examples 27-34, wherein the introducer sheath comprises a hub coupled to a proximal end of the introducer sheath, and wherein the actuatable hemostasis valve comprises a sealing bladder in the hub, and wherein actuating the actuatable hemostasis valve in the introducer sheath to expand away from the elongate shaft comprises removing fluid from the hub.
Example 36 is the method of any of Examples 27-35, wherein the introducer sheath comprises a hub coupled to a proximal end of the introducer sheath, the method further comprising purging the introducer sheath by introducing a fluid into the hub.
Example 37 is the method of any of Examples 27-36, further comprising slidably disposing a dilator through the introducer sheath.
Example 38 is the method of any of Examples 27-37, wherein the medical device comprises a prosthetic cardiac valve.
Example 39 is the method of any of Examples 27-38, wherein the elongate shaft is a delivery catheter carrying the medical device.
In Example 40, the apparatuses, systems or methods of any one or any combination of Examples 1-39 can optionally be configured such that all elements or options recited are available to use or select from.
The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific examples in which the invention can be practiced. These examples are also referred to herein as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.
In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls.
In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.
The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other examples can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed example. Thus, the following claims are hereby incorporated into the Detailed Description as examples or examples, with each claim standing on its own as a separate example, and it is contemplated that such examples can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.
Claims
1. An introducer sheath comprising:
- an elongate shaft having a proximal end, a distal end, and a lumen extending therebetween;
- a hub coupled to the proximal end of the elongate shaft, the hub having a lumen extending therethrough, and the hub lumen fluidly coupled with the elongate shaft lumen;
- an actuatable hemostasis valve disposed in the huh forming an annular region therebetween, the annular region fluidly isolated from the lumen in the hub and the lumen in the elongate shaft, the actuatable hemostasis valve actuatable between an open configuration and a closed configuration,
- wherein in the open configuration the actuatable hemostasis valve is disposed in an expanded configuration that allows fluid to flow past the actuatable hemostasis valve, and
- wherein in the closed configuration the actuatable hemostasis valve is disposed in a collapsed configuration that seals the hub lumen and prevents fluid from flowing past the actuatable hemostasis valve; and
- a single fluid port fluidly coupled with the annular region,
- wherein introduction of a fluid into the single fluid port fills the annular region with the fluid thereby moving the actuatable hemostasis valve into the closed configuration, and
- wherein removal of the fluid from the annular region via the single fluid port moves the actuatable hemostasis valve into the open configuration;
- wherein the annular region of the actuatable hemostasis valve is configured to remain in the open configuration when not filled with fluid.
2. The sheath of claim 1, further comprising a purging straw slidably disposed in the hub lumen, the purging straw comprising an elongate shaft with a proximal end, a distal end, and a lumen extending therebetween.
3. The sheath of claim 2, wherein in the closed configuration the actuatable hemostasis valve is in the collapsed configuration and is configured to collapse against the purging straw and prevent axial movement of the purging straw relative to the hub.
4. The sheath of claim 2, wherein in the closed configuration the actuatable hemostasis valve is in the collapsed configuration and is configured to collapse against a catheter disposed in the hub lumen and prevent axial movement of the catheter relative to the hub.
5. The sheath of claim 2, wherein the purging straw comprises a stopping element coupled to the proximal end of the purging straw, the stopping element configured to limit advancement of the purging straw into the hub lumen.
6. The sheath of claim 2, wherein the purging straw comprises a flared funnel coupled to a distal end of the purging straw.
7. The sheath of claim 6, wherein the flared funnel is self-expanding and comprises a coating or a cover coupled thereto.
8. The sheath of claim 1, wherein the actuatable hemostasis valve is biased to the open configuration.
9. The sheath of claim 1, further comprising a dilator with a tapered distal tip, the dilator slidably disposed through the elongate shaft lumen.
10. The sheath of claim 1, wherein the actuatable hemostasis valve comprises a sealing bladder having an expanded configuration and a collapsed configuration, wherein in the expanded configuration the elongate shaft lumen is patent, and wherein in the collapsed configuration the elongate shaft lumen is obstructed.
11. The sheath of claim 1, wherein the actuatable hemostasis valve comprises a plurality of support elements, a proximal sealing element, a distal sealing element and a sealing bladder, and
- wherein the hub comprises a hub body and a hub cap,
- wherein opposite ends of the sealing bladder are coupled to the proximal and the distal sealing elements,
- wherein the plurality of support elements are disposed between the proximal and the distal sealing elements,
- wherein the actuatable hemostasis valve is disposed in the hub body, and
- wherein the hub cap is coupled to a proximal end of the hub body.
12. The sheath of claim 1, further comprising a distal valve connected to the hub distal of the actuatable hemostasis valve, the distal valve biased to a closed position.
13. The sheath of claim 1, further comprising an external fluid source coupled to the single fluid port, the external fluid source located outside of the hub.
14. A system for introducing a medical device into a patient, said system comprising:
- an introducer sheath comprising an elongate shaft, a hub coupled to a proximal end of the elongate shaft, and an actuatable hemostasis valve disposed in the hub forming an annular region therebetween,
- the annular region fluidly isolated from the elongate shaft,
- the actuatable hemostasis valve actuatable between an open configuration and closed configuration, wherein in the open configuration fluid is configured to flow past the actuatable hemostasis valve, and wherein in the closed configuration the fluid is prevented from flowing past the actuatable hemostasis valve,
- a single fluid port fluidly coupled with the annular region, and
- an external pressurization device coupled to the hub via a fluid line at the single fluid port to introduce and remove fluid into the single fluid port,
- wherein introduction of a fluid into the single fluid port fills the annular region with the fluid thereby moving the actuatable hemostasis valve into the closed configuration, and
- wherein removal of the fluid from the annular region via the single fluid port moves the actuatable hemostasis valve into the open configuration.
15. The system of claim 14, further comprising a purging straw slidably disposed in the introducer sheath, wherein the purging straw comprises an elongate shaft with a lumen extending therethrough.
16. The system of claim 15, wherein the actuatable hemostasis valve in the closed configuration engages the purging straw and prevents axial movement of the purging straw relative to the introducer sheath.
17. The system of claim 15, wherein the purging straw comprises a stopping element coupled to a proximal end of the purging straw, the stopping element configured to limit advancement of the purging straw into the introducer sheath.
18. The system of claim 15, wherein the purging straw comprises a flared funnel coupled to a distal end of the purging straw.
19. The system of claim 18, wherein the flared funnel is self-expanding.
20. The system of claim 18, wherein the flared funnel comprises a coating or cover coupled thereto.
21. The system of claim 14, further comprising a dilator with a tapered distal tip slidably disposed in the introducer sheath.
22. The system of claim 14, further comprising a delivery catheter slidably disposed in the introducer sheath.
23. The system of claim 22, wherein the delivery catheter comprises a delivery catheter carrying a prosthetic cardiac valve.
24. The system of claim 14, wherein the actuatable hemostasis valve comprises a sealing bladder having an expanded configuration and a collapsed configuration, wherein in the expanded configuration fluid is configured to flow past the actuatable hemostasis valve, and wherein in the collapsed configuration fluid is Obstructed from flowing past the actuatable hemostasis valve.
25. The sheath of claim 14, further comprising a distal valve connected to the hub distal of the actuatable hemostasis valve, the distal valve comprising a duckbill valve or flap valve that is biased to a closed position.
26. The sheath of claim 14, wherein the external pressurization source comprises a manually operated syringe.
27. A method of introducing a medical device into a patient, said method comprising
- inserting an introducer sheath into a blood vessel;
- advancing an elongate shaft of the medical device into an actuatable hemostasis valve in a hub of the introducer sheath, the actuatable hemostasis valve being defaulted to an open state;
- slidably disposing the elongate shaft into a lumen in the introducer sheath;
- advancing the medical device through the actuatable hemostasis valve and the introducer sheath to a target treatment area;
- actuating the actuatable hemostasis valve to collapse against the elongate shaft thereby preventing fluid from flowing past the actuatable hemostasis valve, wherein an annular region is disposed between the actuatable hemostasis valve and the hub, the annular region fluidly isolated from the lumen,
- wherein actuating the actuatable hemostasis valve comprises introducing a fluid into a single fluid port fluidly coupled with the annular region thereby filling the annular region with the fluid and moving the actuatable hemostasis valve into a closed configuration;
- performing a treatment on the patient at the target treatment area with the medical device;
- actuating the actuatable hemostasis valve in the introducer sheath to expand away from the elongate shaft thereby allowing fluid to flow past the actuatable hemostasis valve,
- wherein actuating the actuatable hemostasis valve to expand away comprises removing the fluid from the annular region via the single fluid port thereby moving the actuating hemostasis valve into an open configuration; and
- removing the elongate shaft from the introducer sheath.
28. The method of claim 27, wherein the actuatable hemostasis valve comprises a sealing bladder and wherein actuating the actuatable hemostasis valve to collapse against the elongate shaft comprises collapsing the sealing bladder around the elongate shaft thereby constraining axial movement of the elongate shaft relative to the introducer sheath.
29. The method of claim 27, wherein the actuatable hemostasis valve comprises a sealing bladder and wherein actuating the actuatable hemostasis valve to expand away from the elongate shaft comprises expanding the sealing bladder away from the elongate shaft thereby allowing axial movement of the elongate shaft relative to the introducer sheath.
30. The method of claim 27, wherein the elongate shaft comprises a purging straw, the method further comprising filling the purging straw with a liquid and purging a gas out of the purging straw.
31. The method of claim 30, wherein slidably disposing the elongate shaft comprises advancing the purging straw until a stopping element on a proximal end of the purging straw abuts a proximal portion of the introducer sheath.
32. The method of claim 30, further comprising radially expanding a flared funnel on a distal end of the purging straw to facilitate recapture of the medical device.
33. The method of claim 27, further comprising purging the introducer sheath by introducing a fluid into the hub.
34. The method of claim 27, further comprising slidably disposing a dilator through the introducer sheath.
35. The method of claim 27, wherein the medical device comprises a prosthetic cardiac valve.
36. The method of claim 27, wherein the elongate shaft is a delivery catheter carrying the medical device.
37. The method of claim 27, further comprising advancing the medical device through a distal valve disposed in the hub distal of the actuatable hemostasis valve.
38. The method of claim 27, further comprising:
- operating an external pressurization source coupled to the single fluid port to collapse and expand the actuatable hemostasis valve,
- wherein: in a closed configuration the actuatable hemostasis valve is pressurized with actuation fluid from the external pressurization source; and in an open configuration the actuatable hemostasis valve is free of actuation fluid.
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2874568 | January 2018 | EP |
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2967869 | January 2018 | EP |
3033047 | January 2018 | EP |
3037065 | January 2018 | EP |
3049025 | January 2018 | EP |
3052052 | January 2018 | EP |
3078350 | January 2018 | EP |
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2197512 | February 2018 | EP |
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2736544 | February 2018 | EP |
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2886082 | February 2018 | EP |
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2934392 | February 2018 | EP |
3150173 | February 2018 | EP |
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1945112 | May 2018 | EP |
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2797556 | August 2018 | EP |
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2854711 | August 2018 | EP |
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2506777 | November 2020 | EP |
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Type: Grant
Filed: May 20, 2020
Date of Patent: Oct 10, 2023
Patent Publication Number: 20200368514
Assignee: Neovasc Tiara Inc. (Richmond)
Inventors: Aaron J. Chalekian (Savage, MN), Kellen Bodell (Plymouth, MN), Eric Soun-Sang Fung (Vancouver), Karen Tsoek-Ji Wong (Richmond)
Primary Examiner: Jason E Flick
Application Number: 16/879,416
International Classification: A61M 39/06 (20060101); A61M 39/20 (20060101);